Pharmacovigilance safety expert vs scientist

Differences between pharmacovigilance safety expert and scientist duties and responsibilities

Pharmacovigilance safety expert example responsibilities.

• Manage compliance issues, and provide feedback for risk assessments within safety/regulatory regulations for FDA reporting.
• Demonstrate and effectively used knowledge of FDA, ICH and GCP and safety reporting guidelines.
• Perform adequate duplicate search in database prior to book-in and creating cases in Argus.
• Develop and maintain training materials using PowerPoint presentations and computer-base training for new and current employees.
• Develop an ELISA biosensor system that detects toxins in food.

Scientist example responsibilities.

• Lead a cross-functional team to return an HIV combination product to market on random-access instrument.
• Design the VERIS HIV-1 quantitative PCR assay which achieve Conformit Europ enne (CE) marking.
• Manage an elemental analytical laboratory that include operating, maintaining and troubleshooting an ICP-OES, ICPMS, MXRF, and IC.
• Develop and manage third party claim investigations and contractor remedial oversight for various insurance companies.
• Manage study protocols and study conduct, intimately involve in the toxicology and pharmacokinetic study protocol development process.
• Manage sample inventory via in-house laboratory information management system (LIMS) and implement additional systems for sample and chemical organization.
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